{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ocala",
      "address_1": "1210 SW 33rd Avenue",
      "reason_for_recall": "Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.",
      "address_2": "",
      "product_quantity": "102 units",
      "code_info": "Rx #'s:    0396447      0391904    0396678    0393251    0400335      0402500    0352474    0368241    0387963                      0394942    0402089        0394942          0400335    0352474      0368241    0393251      0395043      0368241        0393251    0403936        0409994    0391904    0349660    0368241        0388163      0390614            0391904              0401994    0402332    0402500    0393985    0368241    0403168    0402227    0403032    0395193        0396679    0397454    0396679    0387480    0387514    0397147    0401881      0405105    0409255    0397147    0403630    0397147    0401846        0387647    0390992              0397147    0403742    0402848    0402848    0402848    0399288",
      "center_classification_date": "20120810",
      "distribution_pattern": "Nationwide, Bahamas, Columbia, Dominican Republic, Grand Cayman, Guatemala, Poland, Santo Domingo, Venezuela, West Indies",
      "state": "FL",
      "product_description": "TRYPAN BLUE SOLUTION, P.F. 0.04% OPHTHALMIC\t10 ML;  \t  TRYPAN BLUE SOLUTION, P.F. 0.05% OPHTHALMIC\t0.5 ML  \t1.5 ML  \t10 ML  \t  \t  \t12 ML  \t2 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t2.5 ML  \t  \t  \t  \t  \t3 ML  \t  \t  \t  \t  \t  \t  \t4 ML  \t  \t  \t  \t  \t  \t  \t  \t4.5 ML  \t5 ML  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t  \t6 ML  \t7.5 ML  \t8 ML;  TRYPAN BLUE SOLUTION, P.F. 0.06% OPHTHALMIC\t10 ML  \t  \t2.5 ML;  \t  \t  TRYPAN BLUE SOLUTION, P.F. 0.1% OPHTHALMIC\t1 ML  \t  \t1.5 ML  \t10 ML  \t  \t  \t  \t  \t  \t  \t12 ML  \t2 ML  \t25 ML  \t4 ML  \t  \t  \t5 ML  \t  \t  \t  \t  \t  \t  \t50 ML;  TRYPAN BLUE SOLUTION, P.F. STSL (0.5ML SYRINGE, NO NEEDLE) 0.06% OPHTHALMIC\t10 ML;  TRYPAN BLUE, 0.75ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC\t3 ML  \t4.5 ML  \t9 ML;  TRYPAN BLUE, 1ML SYRINGE, LUER-LOK, STSL 0.1% OPHTHALMIC\t12 ML  (30 DIFFERENT PRODUCTS)",
      "report_date": "20120822",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Franck's Lab Inc., d.b.a. Franck's Compounding Lab",
      "recall_number": "D-1634-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Drugs",
      "event_id": "62443",
      "termination_date": "20140815",
      "more_code_info": "",
      "recall_initiation_date": "20120521",
      "postal_code": "34474-5138",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}